Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-03-17FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for pravastatin sodium, a generic statin, approving changes to the product's la…
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FDA approval · 2025-03-17FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for pravastatin sodium from Accord Healthcare Inc., supporting continued regulatory approval for thi…
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FDA approval · 2025-03-13FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Novadoz Pharmaceuticals LLC)
FDA approved a supplemental application for atorvastatin calcium filed by Novadoz Pharmaceuticals LLC.
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FDA approval · 2025-03-12FDA Approved: ROSUVASTATIN — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' supplemental application for rosuvastatin (generic rosuvastatin), authorizing its marketing in the Unit…
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FDA approval · 2025-03-11FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's supplemental application for atorvastatin calcium, expanding the availability of a generic statin product.
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FDA approval · 2025-02-24FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for pravastatin sodium from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2025-02-24FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for pravastatin sodium submitted by Aurobindo Pharma Limited. This action pertains to the generic pr…
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FDA approval · 2025-02-18FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Quallent)
FDA approved a supplemental application for Pravastatin Sodium submitted by Quallent, indicating an approved change to the product under an …
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FDA approval · 2025-01-14FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for rosuvastatin calcium submitted by Sun Pharmaceutical Industries, Inc., approving an additional f…
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FDA approval · 2025-01-14FDA Approved: ROSUVASTATIN — Supplemental Application (ScieGen Pharmaceuticals, Inc.)
The FDA approved a supplemental application for rosuvastatin submitted by ScieGen Pharmaceuticals, enabling the marketing of a generic rosuv…
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FDA approval · 2025-01-14FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Rosuvastatin Calcium from Ascend Laboratories, LLC, supporting the continued availability of a r…
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FDA approval · 2025-01-14FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Umedica Laboratories USA Inc.)
The FDA granted supplemental approval for rosuvastatin calcium under an ANDA for Umedica Laboratories USA Inc., confirming the generic produ…
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FDA approval · 2025-01-10FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Biocon Pharma Inc.)
FDA approved Biocon Pharma Inc.'s supplemental application for atorvastatin calcium, authorizing its continued marketing as a generic statin…
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FDA approval · 2024-12-26FDA Approved: CHOLESTYRAMINE — Supplemental Application (EPIC PHARMA, LLC)
FDA approved a supplemental application for cholestyramine from EPIC PHARMA, LLC.
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FDA approval · 2024-12-19FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for the ezetimibe and simvastatin combination from Amneal Pharmaceuticals NY LLC.
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FDA approval · 2024-12-17FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for atorvastatin calcium (generic) from Ascend Laboratories, LLC, for this ANDA, approving regulator…
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FDA approval · 2024-12-09FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for a generic rosuvastatin calcium product from Quallent Pharmaceuticals Health LLC under ANDA20…
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FDA approval · 2024-12-05FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for atorvastatin calcium from Mylan Pharmaceuticals Inc., authorizing the continued marketing of the…
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FDA approval · 2024-12-04FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)
FDA approved a supplemental application for atorvastatin calcium from Sun Pharmaceutical Industries Inc., enabling the generic atorvastatin …
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FDA approval · 2024-12-03FDA Approved: COLESTIPOL HYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved an Abbreviated New Drug Application for Colestipol hydrochloride by Ingenus Pharmaceuticals, LLC, establishing a generic versio…
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FDA approval · 2024-11-27FDA Approved: SIMVASTATIN — Original Application (Westminster Pharmaceuticals, LLC)
FDA approved Westminster Pharmaceuticals' original application for a generic simvastatin product, adding another generic option for choleste…
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FDA approval · 2024-11-20FDA Approved: REPATHA — Supplemental Application (Amgen USA Inc.)
The FDA approved a supplemental application for Repatha (evolocumab) submitted by Amgen USA Inc.
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FDA approval · 2024-11-13FDA Approved: FENOFIBRATE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals Limited's fenofibrate as an Original Application generic (ANDA 210248). This marks the approval of a g…
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FDA approval · 2024-11-06FDA Approved: ROSUVASTATIN — Original Application (Macleods Pharmaceuticals Limited)
FDA approved the original application for rosuvastatin by Macleods Pharmaceuticals Limited, establishing a generic rosuvastatin product. Thi…
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FDA approval · 2024-11-04FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for the fixed-dose combination of amlodipine and atorvastatin by Prasco Laboratories.